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Atellica CH Ca 11645759

by Siemens Healthcare Diagnostics Inc.

Ref 11645759Model IVDR_67_TTN_DUB-C_B_REAG_CA_c

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

Recall on shared 510(k) K991576; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686901672VZ Basic UDI-DI 00630414654041UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414654041 UDI-DI Date8 Apr 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-1498-2022 FDA Class II initiated 28 Jun 2022 on shared 510(k) K991576

    Falsely Elevated Atellica CH Microalbumin_2 (ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.

    • Terminated Z-2062-2018 FDA Class II initiated 27 Mar 2018 on shared 510(k) K991576

    Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.

    • Terminated Z-1658-2016 FDA Class II initiated 17 Mar 2016 on shared 510(k) K991576

    Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Atellica CH Calcium (Ca) EUDAMED
Atellica CH Ca GUDID
Generic Name
Calcium (Ca2+) IVD, kit, spectrophotometry
Device Name
IVDR_67_TTN_DUB-C_B_REAG_CA_c
Model / Ref / Catalog
11645759, IVDR_67_TTN_DUB-C_B_REAG_CA_c
Primary DI / UDI-DI
00630414654041
Basic UDI-DI
0405686901672VZ
Unit of Use DI
00630414322117
510(k) Number
FDA Product Code
CIC
EMDN Code
W01010303 Calcium
GMDN Term
Calcium (Ca2+) IVD, kit, spectrophotometry
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
862.1145
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class II

Related devices

Cleared under the same submission (K991576)

Show all (12)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Reagent
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No